Recombinant activated clotting factor VII (rFVIIa) in the treatment of surgical and spontaneous bleeding episodes in hemophilic patients

Figures & data

Table 1 Efficacy of rFVIIa at different bolus dose regimens for the treatment of acute non-surgical bleeding in hemophilia A and B patients with inhibitors

Study	Type of bleeding	Number of episodes (no. of patients, where available)	Dose (μg/kg)	Number of doses used per bleed	Effective response (%)
Lusher et al 1998^RCT	Joint/muscle/mucocutaneous	Joint–59 Muscle–15	35	Joint–2.7 Muscle–3.5	71 53
Lusher et al 1998^RCT	Joint/muscle/mucocutaneous	Joint–85 Muscle–14	70	Joint–3.1 Muscle–3.6	71 72
Bech 1996a	Joints/muscle	494(111)	60–120	11–65	Joints–79 Muscle–65
Rice and Savidge 1996a	Central nervous system (CNS)	29 (21)	80–100	2–332	84
Arkin et al 1998a	Intracranial	13 (12)	90	96.9	83
Scharrer 1999a	Joints and other sites	45(23)	90	46.8	69
Kenet et al 2003	Joints and others	114 (3)	300	1	83b
Parameswaran et al 2005	Joint/muscle/mucocutaneous	146	<100	4.3	85
		154	100–150	5.2	84
		136	150–200	3.4	84
		119	>200	2.3	97
Santagostino et al 2006^RCT	Joints	36(18)	270	1	64b
Kavakli et al 2006^RCT	Joints	20(20)	270	1	65b

a Studies include non-hemophilic patients and were part of the Compassionate Use Program and Emergency Use Study.

b Results of efficacy was analyzed after single dose of rFVIIa (as allowed by protocols).

Abbreviations: RCT, randomized controlled trials.

Table 2 Unresolved issues with recombinant activated factor VII use in hemophiliacs

Optimal dosing strategies Modalities for measuring and monitoring response Cost-effectiveness The place for continuous infusion Thrombotic risks

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